FlexFactory single-use platform

Reduce risks and realize capacity faster with the FlexFactory biomanufacturing platform.

Improve process economy with a single-use platform

Implementing a FlexFactory platform enables increased productivity and efficiency. It also reduces risks and costs associated with expanding cGMP manufacturing capacity.

Support throughout the journey

We manage almost every aspect of your FlexFactory or KUBio project from initial development through final construction and assembly.

Agile automation platform

The configurable FlexFactory design includes a choice of automation schemes, including; unit operation automation, documentation automation or plant scale automation. GE will integrate automation to meet facility requirements to provide:

  • Centralized process monitoring and control
  • 21 CFR Part 11 compliant-ready solution
  • Process data management and trending

FlexFactory is configurable to include GE’s single-use systems or a hybrid solution including multiple systems.

Improve operational efficiency in biomanufacturing with comprehensive automation solutions.


Reduce operational costs

The FlexFactory biomanufacturing platform can provide reduced operational costs through faster deployment, accelerated production turnaround, multiproduct processing, and scalable production.

  • Integrated automation
  • Connectivity with single-use tubing sets
  • Single-use technology
  • More than 100 kg of mAbs produced per year
  • Centralized monitoring and control enabled for 21 CFR part 11 compliance

Answers to our most often-asked questions on the FlexFactory platform

A. FlexFactory is a bioprocess platform using predominantly single-use technology. It comprises distinct unit operations connected via single-use tubing sets and can include a variety of automation schemes. KUBio is a cGMP-compliant facility that includes a FlexFactory bioprocess platform for the production of mAbs.

A. Yes. The FlexFactory platform is designed to fit a new or an existing manufacturing plant and can be set up for production at a site of your choice. A FlexFactory installation will be fully qualified and ready to run 6 to 9 months after completing conceptual design. Conceptual design can take 2 to 3 months, so the overall project timeline is between 9 and 12 months.

A. The FlexFactory platform can be configured for production bioreactor scales of 200, 500, 1000, or 2000 L and the footprint of the production platform depends on the chosen configuration and your production capacity needs. However, a 2000 L FlexFactory setup will require a processing/manufacturing area footprint of approximately 400 m2 while a 500 L setup will require slightly less room. The overall building including warehouse, laboratory, office, and utility space is approximately 2000 m2.

A. The FlexFactory platform can be configured for the manufacture of biologics such mAbs or vaccines.

A. The FlexFactory platform can be used for both pilot- and commercial-scale production and it is possible to run up to 4 × 2000 L bioreactors with a single downstream processing train. In a mAb process, product titers are typically 2 to 4 g/L and a 2000 L bioreactor with a process yield of 70% can be expected to have an output capacity of over 100 kg of product per year.

A. Yes. We have extensive experience of transferring traditional stainless steel biomanufacturing processes to our FlexFactory single-use solutions. Our process development team will support your transition and can provide training using our in-house FlexFactory platform in Massachusetts, USA.

A. Yes. We have installed dozens of FlexFactory processing lines around the world that are operational today. FlexFactory single use equipment includes Xcellerex bioreactors and mixers, Wave bioreactors and GE AKTA chromatography systems. We have successfully integrated Wonderware and DeltaV automation systems in a number of locations.

A. The FlexFactory platform is designed to streamline facility development projects and offers flexibility for single or multiproduct capacity requirements. The turnkey project plan provides a choice in equipment, automation and ongoing support that ensures that each project enables the desired outcome.

A. A FlexFactory platform will include the necessary process equipment from cell culture expansion systems through your seed and production bioreactors to bulk drug substance formulation. Cell culture harvest clarification is performed with a harvest pump and harvest filter holder. ÄKTA chromatography systems can be incorporated for protein purification. Viral filtration is performed using a viral filtration pump and viral filtration filter holder and then on to a final concentration TFF/UFDF system. Lastly, a solution for fill and storage of bulk drug substance is provided.

A. Processing with single-use technology allows you to proceed directly to production instead of spending months performing CIP and SIP validation and qualification. Removing the need for CIP and SIP capability reduces overall plant footprint, capital cost, and the number of unit operations compared with an equivalent traditional stainless steel based process.

A. A Factory can include:

  • The choice of a WAVE Bioreactor systems for cell culture expansion and Xcellerex XDR bioreactors for seed bioreactors and production bioreactors.
  • ÄKTA chromatography systems for protein purification operations.
  • Xcellerex XDUO and XDM Quad Mixing Systems automate the mixing of buffers, media, and product intermediates.
  • Equipment within a unit operation and connections between unit operations can utilize ReadytoProcess single-use tubing.

Automation hardware and software can be configured to enable monitoring, control, and analysis of the manufacturing process from multiple operator workstations and remote access for maintenance and troubleshooting by GE technicians.

A. The standard FlexFactory configuration typically includes an automated TFF/UFDF system and a choice of filters and filter holders for use during harvest clarification and viral filtration steps that we source from a range of vendors. However, we can also work with you to integrate additional equipment for your specific processing needs. For added peace of mind, we offer a preventive maintenance service for non-GE equipment.

A. We have a process review with you to explain all possible disposable solutions that GE can provide. A disposable solution will be discussed for each unit operation within the scope of FlexFactory. Disposables will include all bags for bioreactor, mixer, and storage applications. Tube sets for all liquid transfers and downstream unit operations will be accounted for as well. Tube sets might include integral sensors or filers depending upon their intended use.

A. A GE team of over 100 finance professionals offers a wide range of advisory and arrangement services and leverage a global network of commercial banks, export credit agencies, multilateral agencies, and insurance companies. We can facilitate loans, leases, insurance to mitigate risk and export credit agencies and multilateral financing. We also provide advisory services to assist with project development and financing.